standards (e.g. iso mdd ansi etc.)

  1. J

    Plunger Rod for Syringe - Is there a standard for piston rods?

    Hi, I would like to know if there is a standard for syringe plunger rods. I know ISO 11040 but I can not find anything on the piston rods. Thank you. Jojo.
  2. L

    Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards

    One of my friend gets notices when an ISO standard was revised, he has the access to the public draft copies. I asked but he didn't tell exactly how he got the access. Is it a subscription thing [ISO member] or something else? Thanks.
  3. G

    Calibration: Conforming to ISO9001 Requirements

    Hey, I am currently starting to create documents for my company's quality department (exciting!). From my understanding to meet ISO9001(2015), you need to be able to quantify that you are meeting the specs/requirements implemented by your company through its various processes. Basically, can...
  4. M

    Proper ISO standard for Pressure Testing and Leak Rates

    I'm having a tough time finding the proper ISO standard for Pressure Testing. Specifically I'm trying to figure out if within this standard there is a method for testing leak rates with air and being able to connect that leak rate to a hydro-static rate. I know air molecules are smaller...
  5. Marcelo Antunes

    Informational Some ISO guides for standardization work

    Guidance on the Systematic Review process in ISO Guidance on new work My ISO job – What delegates and experts need to know How to write standards – Tips for standards writers ISO Code of Conduct for the technical work Posted at Marcelo's Medicaldevice.expert website... You may comment and...
  6. DuncanGibbons

    Additive Manufacturing/3D printing for aerospace (certification procedure)

    Hi all Im looking into developing a certification framework for Additive Manufacturing parts for aerospace. The aerospace industry isnt my specialty and I was wondering if anyone has any resources/links to aid me in understanding exactly what documents/tests are needed in order to be able to...
  7. B

    How to assess which directives and standards apply - Brewing and distilling products

    Our company manufactures brewing and distilling products, to include Stills, brew houses, fermentation tanks, brite tanks, etc. I am new to CE and wish to find out which European Directives apply to our equipment. Any advice? Bradford
  8. Marcelo Antunes

    Informational CDRH Proposes New IMDRF Work Item on Standards

    CDRH Proposes New IMDRF Work Item on Standards Posted at Marcelo's Medicaldevice.expert website... You may comment and discuss in this discussion thread.
  9. Marcelo Antunes

    Informational USFDA – FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051

    FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 051 Continue reading at Marcelo's Medicaldevice.expert website... You may also comment and discuss in this discussion thread.
  10. Marc

    MIL-STD-810H - 31 January 2019

    MIL-STD-810 was my "bible" back in the 1980's when I was writing Environmental Design Criteria Test Plans for electronic assemblies. It has been quite a while since I used it. I was a senior member of the IEST when I retired and was visiting the site this morning, mostly out of nostalgia...
  11. Ashland78

    IATF 16949 Internal Audit Checklist

    I am tasked with getting an internal audit team to audit all elements of the IATF standard in a 3 year period. I have no $ to purchase software to have questions and checklists available for using. I am going to start our audits in February and have sections 5.1, 5.2 , 5.3 and 8.1, 8.2 to...
  12. P

    Usability/human factors engineering requirement (standard) for IVD medical device

    Dear All, Merry Christmas and Happy New Year, Just want to check whether anyone has a summary or a list of requirements for usability/human factors engineering, including standards (e.g. CLSI or others) specifically for IVD medical devices. I know that there was "GP14-A Labeling of Home-Use In...
  13. Ed Panek

    Do standards have performance reviews?

    For example, when a new ISO standard is released, does that process go through a Management Review with CAPAs? If a new standard is released, how does the committee prove it is effective to improve/control performance? What metrics are used?
  14. M

    ASTM A6 Material Standard - Section Nominal Sizes

    I'm hoping this is considered the right sub thread for this type of question. I'm doing some research for my current company and its all realated to the standard C channel we purchase. The ASTM A6 standard is pretty clear except when defining what the section nominal sizes are. Would that...
  15. D

    Raw Material chemical/Tensile Requirements Specifications (QQ-A-250/4, etc)

    When I receive raw material (aluminum, steel, etc) and verify the actual properties to the specification (QQ-A-250/4, etc) I have to have the actual specification, in the latest revision. Is there a place or a service that provides the chemical/tensile requirements for raw material such as this...
  16. M

    Updates to EN 62366 & ISO 14971?

    Hi Everyone! I recently got an email notifying me of some upcoming changes/edits to the EN 62366 and ISO 14971 standards: EN 62366-1:2015 The email said there is a corrigendum (EN 62366-1:2015/AC:2018), but I've been unable to find any further information. Closest thing I could find is a 2016...
  17. L

    What are the rules on significance of digits in numbers in IEC/ISO standards?

    Hi, Maybe a lack of search skills, but I cannot find any indication or referral in the standards like the 60601-1 we have right now (we cannot afford to buy them all) on how to interpret the significance of the last digit of values. My late science teacher hammered on the notion that the...
  18. M

    Plating standards - Where to find information

    It looks like I might have to purchase the AMS 2417 Nickel plating standard. Currently this is at rev. J (09-2013). I have heard that standards get reviewed/revised every 5 years or so. I don't want to purchase if the standard is currently being revised or will be within the next few months...
  19. C

    Where to buy the latest MHLW, Canada MDR, Brazil medical device regulations

    Hello, Is there one website that I can get, buy, download the latest MHLW, Canada MDR, Brazil regulations for medical devices? Or if you have the sites you use for each one will be fine too. Thank you,
  20. S

    Virtual manufacturers/OEM - CE/ISO requirements

    Hi all, we(as a virtual manufacturer) want to add few OEM products in our product list and sell those products in our name and also put CE marking. The OEM already have CE. Can we put "manufactured by" our address and use their CE marking. or shall we get the technical file from...
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